NCT07040046

HS-10542 Study in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and the Food Effect on the Pharmacokinetics of HS-10542 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants.

Detailed description

This study consists of two parts, of which the Part I consists of the single ascending dose (SAD) study and the food effect (FE) study, while the Part II consists of the multiple ascending dose (MAD) study. The Part I and Part II form this randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK and PD characteristics, as well as the food effect on pharmacokinetics of HS-10542 in Chinese healthy adult participants after single and multiple oral doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HS-10542	1. SAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1. 2. Food Effect \[FE\] study：HS-10542 capsule (in one predefined dose cohort ) will be administered orally once on Day 15.
DRUG	HS-10542 Placebo	SAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1
DRUG	HS-10542	MAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.
DRUG	HS-10542 Placebo	MAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.

Timeline

• Start date: 2025-05-16
• Primary completion: 2025-12-04
• Completion: 2026-03-31
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: China